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Elders Didn’t Reveal That Arkansas Was Distributing Defective Condoms

July 22, 1993 GMT

WASHINGTON (AP) _ Surgeon General-designate Joycelyn Elders decided to withhold information on possible defects in condoms that were being given to schools and clinics in Arkansas while she was state health director.

The state was distributing more than 1 million condoms a year, but officials concluded that telling the public the condoms had flunked leakage and breakage tests would cause an unnecessary scare.

″It was the judgment of Tom Butler (deputy director of the Arkansas Health Department) after meeting with counsel and other senior members of the staff that because at least 95 percent of the condoms in the worst batch were still effective, to have made a public announcement might have undermined public confidence in condoms,″ Victor Zonana, a spokesman for Elders at the federal Department of Health and Human Services, said Wednesday.

″The resulting non-use of condoms would have been a greater risk to public health, department officials concluded. It was a judgment call, and it’s one the (Arkansas) department stands by,″ Zonana said.

″Dr. Elders was notified of this conclusion and concurred in the professional judgment of her senior staff,″ Zonana said.

Elders has been a vocal supporter of condom distribution, including in the schools, to stem teen-age pregnancies and control the spread of disease.

She has not been giving interviews prior to her confirmation hearing as surgeon general, now scheduled for Friday. A Senate panel postponed hearings on her nomination last week after opponents raised questions about her finances. Conservatives also oppose Elders because of her outspoken support of abortion rights and sex education for children.

Government documents obtained by The Associated Press show that Arkansas was distributing condoms bought from the same supplier, Ansell Inc. of Dothan, Ala., which sold them under the brand name LifeStyle.

Tests on four lots of the Arkansas condoms by the Food and Drug Administration found a defective rate more than 10 times higher than the limit set by the agency. The FDA allows a defective rate of four condoms per thousand, but the agency’s tests found one lot with a defective rate of five per hundred.

The company complained that the tests themselves were defective because the FDA was using old equipment.

The rate was high enough that the FDA moved immediately to get a court order that would allow U.S. marshals to seize the condoms, according to the documents obtained by the AP.

The Arkansas Health Department first complained to the manufacturer in December 1990 when it sent back 50 condoms from a high school clinic where there had been complaints about them breaking. Two months later the manufacturer wrote back it hadn’t gotten any other complaints on that batch of condoms.

The company also sent along a 12 dozen LifeStyles Extra Strength condoms ″for your use as samples.″

The state Health Department got more complaints from local health officials starting in February 1992, and on July 16, 1992 - the same day then-Gov. Bill Clinton accepted the Democratic presidential nomination - the state ordered a halt to distribution of condoms in state inventories ″until the reported problems of ruptures can be more thoroughly investigated.″

The state got another supplier, and condom distribution has resumed.

Dr. Dick Nugent, medical director of the Health Department’s maternal and child health section, said the department received 10 complaints of problems with condom breakage from four health units in the state.

Donnie Smith, chief administrator for the maternal and child health section, said the state Health Department could not determine whether any of the four school-based health clinics that dispense condoms to students received any of the defective condoms.

People coming to public health agencies for AIDS testing were given condoms to use before their test results were ready. The Baxter County health unit sent this memo to Little Rock on June 24, 1992:

″Three successive HIV antibody test clients who were issued LifeStyle condoms during their pre-test counseling stated that the condoms broke in EVERY use.″

The FDA on Aug. 27, 1992, approved seizing the defective lots of condoms and drafted a complaint to file in U.S. District Court in Arkansas asking for power to do so.

Ansell, the condom manufacturer, wrote the FDA on Sept. 3, saying it was recalling the condoms. Five days later, the FDA withdrew its seizure approval.

But some 10 months later, the FDA still has not issued a public notification of the recall, as is the agency’s practice.

FDA spokesman Jim O’Hara said the reason no public notice has been made yet is because the paperwork hasn’t been completed.